Bonum Certa Men Certa

European Patents Found to be Invalid and Deemed Impotent in the Highest British Court (Again)

It's about the tadalafil generic

Just gimme the hands



Summary: "Just gimme the patent," says every greedy corporation looking to ban its competition (including generics) and facilitate monopoly pricing; the problem is, the EPO keeps granting invalid patents that take a lot of time and money to formally invalidate (in courts), as Actavis v ICOS has just shown

THE number of patents granted by the U.S. Patent and Trademark Office (USPTO) declined last year after certainty associated with these patents had declined and then number of patent lawsuits had totally collapsed. We now see something similar going on in Europe. Was it inevitable? Couldn't we learn from the mistakes of American lawmakers and USPTO officials?



We are pleased to see that IP Kat (Rose Hughes) has recently been covering some cases that relate to the European Patent Office (EPO). Hughes is doing an OK job without coming across as a patent extremist like the Bristows staff at IP Kat and yesterday she wrote this article about a (British) Supreme Court outcome. Yet another EPO-granted patent has been found to be nonsense:

This morning, the UK Supreme Court delivered its decision in Actavis v ICOS [2019] USKC 15, upholding the Court of Appeal's decision that ICOS's dosage regimen patent was obvious. In doing so, the Supreme Court (in a welcome change...) has followed the previous approach of the lower courts to the question of inventive step in both the UK courts and in the jurisprudence of the EPO.

The patent in question related to tadalafil (branded as CIALIS). Tadalafil is an orally administered drug for treating sexual dysfunction. Tadalafil works in a similar way to Pfizer’s famous blockbuster drug Viagra, but with fewer side effects. The original first medical use patent for tadalafil (EP 0740668, "Daugan") and its associated SPC have both expired. The latest decision related to ICOS's patent (EP 1173181) which claimed a particular dosage regime of tadalafil. Lilly is the exclusive licensee of the patent.

In an attempt to clear the market for their own tadalafil generic, Actavis brought revocation proceedings against the ICOS/Lilly patent. Actavis argued that the claims lacked novelty and inventive step in view of the original tadalafil patent ("Daugan"). The contentious claims related to a dose regime of up to 5mg tadalafil per day. The Court of Appeal, in overturning Mr Justice Birss' decision, found the patent invalid for lack of inventive step (Actavis v ICOS [2017] EWCA Civ 1671). Particularly, it was found that the claimed dose would have been obvious for the skilled person to try (IPKat post here).


Notice that first comment which asks: "Can every one of Lord Hodge's 9 factors be accommodated within Lord Hodge's exposition of the EPO's Problem and Solution Approach? If not all, which ones not?"

“Can every one of Lord Hodge's 9 factors be accommodated within Lord Hodge's exposition of the EPO's Problem and Solution Approach?”
      --Anonymous
Someone "from France" then added: "One important factor seems indeed to be missing, which is the "reasonable expectation of success", even though certain of the listed factors are usually considered for applying this factor. The reasoning that the clinical trial is somewhat a "one way street" (to use EPO standards) is not completely out of scope, but the specific dosage finding that has been identified for optimal effect could, in my view, not have been necessarily derived from this approach (the dosage plateau could not have been expected, considering it seems to necessarily imply some hindsight). I'm not sure I agree with the comment in the post that such a decision is welcome..., I can hardly consider a diverging view between the EPO and national courts to be welcome."

Another anonymous commenter quotes: "The original first medical use patent for tadalafil (EP 0740668, "Daugan") and its associated SPC have both expired."

Then comes the question (or questions): "Doesn't this mean it has already passed through clinical trials? By the courts' logic should a 5mg dose already be known? What have I missed?"

What about public interests as well? Either way, the court has trashed yet another European Patent. Will António Campinos get the message or just keep on lying about quality?

“I can hardly consider a diverging view between the EPO and national courts to be welcome.”
      --Anonymous
Freshfields Bruckhaus Deringer LLP's Laura Whiting and Paul Abbott wrote about it this morning (publication time), calling it "its second patent decision in 6 months" (so rarely do we get to see, at least at this level, just how awful the quality of patents has become).

We'll probably hear a lot more about it in days if not weeks to come.

Recent Techrights' Posts

Speed of GNU/Linux
The media seldom speaks of the dangers of "proprietary software"
Proprietary Windows Versus "Linux" News (Trying to Keep People on Windows, Never Exploring GNU/Linux)
Good editors know better how to recognise threats and not give them lip service
Ensuring That Every Computer User Anywhere in the World Can Take Control of All His or Her Computers
We must fight the people who attack general-purpose computing, in particular those who push this agenda very aggressively inside Linux
Gemini Links 28/04/2025: Autism and Structural Navigation
Links for the day
What Happened to the Open Source Initiative (OSI) Elections: The Purge, the Cover-up, and the Witch-hunts
OSI has gone "full Microsoft"
 
Links 28/04/2025: Canada's Election, Pakistan-India Conflict
Links for the day
Glue Inside Your Pizza (or Why People Will Get Fed Up With Slop)
People are given "answers" from non-intelligence word dumpsters
Links 28/04/2025: Cyberattacks Happening, Chatbots Disappointing, and "Free Speech Under Fire"
Links for the day
Phone Adoption Very Low in Vatican, Windows Usage Fell Nonetheless
Even in places where people still use desktops/laptops most of the time (and have access to these) Windows is gradually losing ground
GNU/Linux 9% in Cuba, Vista 11 Waning, Android Dominant
Microsoft has pretty much lost Cuba
Over at Tux Machines...
GNU/Linux news for the past day
IRC Proceedings: Sunday, April 27, 2025
IRC logs for Sunday, April 27, 2025
In 24 Countries Observed by statCounter Vista 11 is Still Less Than a Quarter of Windows Users Despite All Other Versions Being 'Expired'
They ought to move to GNU/Linux
Links 27/04/2025: Pope Goodbyes, "Politics of Fear", Slop Redux and More Google Shutdowns (Google Debt Had Grown This Year)
Links for the day
Links 27/04/2025: Serenity Dialectics, Hockey Jersey Ethics, and More
Links for the day
Links 27/04/2025: Death of Nest Thermostats, Death of Metaverse
Links for the day
Links 27/04/2025: Projects Workflow and Discovering Technology
Links for the day
Over at Tux Machines...
GNU/Linux news for the past day
IRC Proceedings: Saturday, April 26, 2025
IRC logs for Saturday, April 26, 2025
Microsoft Isn't on the Map in USSR
To them, it's either Google or Yandex
In Central America Windows Became a Small Force
These are countries where Windows used to have well over 95% of the "market"
What's Very Vexing to GAFAM, EPO and Others Is That It's Incredibly Hard to Censor Us (and Nobody Ever Successfully Did That Before)
resist, do not capitulate
Site May be Even Faster Now
It basically takes less than a tenth of a second to serve the page
Receiving SLAPPs and Collecting Them Like Trophies (the SLAPPs Always Fail)
People who file lawsuits bring even more attention to themselves (or to embarrassing statements about them)
Year of GNU/Linux on the Laptop?
It's not happening only in Lenovo
What People Must Understand About the Open Source Initiative (OSI)
some facts about the Open Source Initiative (OSI)
Many of the Scandals Are Interconnected (Overlapping People and Corporations)
We're only getting started
More Copyright Lawsuits Against LLM Slop Providers and Suppliers of LLM Slopfarms Would Benefit Society
It's not just bad for the Web and for society; it's also legally dangerous
Links 26/04/2025: General Assassinated in the Town of Balashikha, US Promoting Seafloor Mining
Links for the day
Links 26/04/2025: Facebook Layoffs Again, Remembering What's Real, and Say No to Mass Surveillance
Links for the day
Links 26/04/2025: NOAA Budget Cuts and "Dog Days Ahead"
Links for the day
In defence of JD Vance, death of Pope Francis
Reprinted with permission from Daniel Pocock
Three Years in Prison for Disney Employee’s ‘Menu Hacking’: The Economic Fallout of Digital Menus
Reprinted with permission from Ryan Farmer
Over at Tux Machines...
GNU/Linux news for the past day
IRC Proceedings: Friday, April 25, 2025
IRC logs for Friday, April 25, 2025